Downloads. Package insert Spanish Lot: – Expiry: 05/ Ed. 8; Package insert French Lot: – Expiry: 05/ Ed. 8; Package insert . Summary [1, 2]. Hemoglobin A1c (HbA1c) is a glycated hemoglobin which is formed by the non-enzymatic reaction of glucose with native hemoglobin. HbA1c FS*. Diagnostic reagent for quantitative in vitro determination of hemoglobin A1c (HbA1c) in whole blood on. DiaSys respons® Order Information.
|Published (Last):||16 February 2005|
|PDF File Size:||7.9 Mb|
|ePub File Size:||2.80 Mb|
|Price:||Free* [*Free Regsitration Required]|
At the present time 54 metalloprotease families are divided into 15 clans, wherein outstanding significance is attributed to the clan MA with 39 families.
Therefore the inventors of the present application set themselves the object of providing a method of determining the amount of glycated haemoglobin HbA1c in a sample and reagents which can be used in that respect, in which the chemical compounds essential to the reaction are present in sufficiently stable form. In most cases the sample will be a sample of fresh diasgs blood. Stabilisation of the Unfolded Hemoglobin Preceding efficient unfolding of haemoglobin and also stabilisation of that unfolded form are of essential significance for accurate measurement of Hb and HbA1c.
To resolve that problem the state of the art proposed for example for the protease thermolysin removing zinc from the theremolysin by chelators, in particular SH group-containing reagents, or by a simple excess of EDTA.
The addition of the SH group-trapping agent should accordingly occur at latest immediately prior to carrying out the HbA1c detection reaction.
QDx Instacheck™ – DiaSys India
After the reaction is substantially concluded photometric determination of the total haemoglobin content of the pre-incubated haemolysate is effected. The constantly low pH-value of the haemolysate in conjunction with the stabilising detergents has the result that the unfolded haemoglobin can be quickly and efficiently broken disays.
The fructosyl amino acid or fructosyl peptide is oxidised by the activity of the enzyme fructosyl amino acid oxidase FAOX or the enzyme fructosyl peptide oxidase FPOXwherein a result of that oxidation step is the production of hydrogen peroxide H 2 O 2. The cleaved glycated peptide is then reacted by the FPOX, wherein hydrogen peroxide is produced upon cleaving of the glycated peptide into peptide and glucosone.
The following reagent preparations by way of example were produced: Besides the above-described method the present invention also proposes reagent kits for use in a method of determining the amount of HbA1c in a sample, which are characterised in that they comprise at least two different solutions in separate containers, wherein the at least two different solutions are uba1c of such a composition that the various aspects of the invention described in detail hereinafter are implemented.
In many aspects of the present invention there is no need for the protease used to lead to given degradation products. Special Embodiments of the Reagent Kits In an embodiment of the invention described in the present application there is provided a reagent kit which includes at least the following three solutions in separate containers: Riasys method according to claim 7, wherein the solution containing the leuco dye for stabilisation of the dye contains at least one thio compound.
Search Expert Search Quick Search. Synthesis of beta-lactam antibacterials using soluble side chain esters and enzyme acylase. Nerolidol, Terpene, and Terpene Deriviative Synthesis.
Changing from Glucose to HbA1c for Diabetes Diagnosis
In certain embodiments of the present invention the molar ratio of chelator: In an embodiment of the present invention the various reagents used in HbA1c determination are brought together in the form of the following solutions which are provided in separate containers: The problem of self-digestion of proteases is already known per se in the state of the art.
The peroxidase already introduced nba1c the composition by way of the first reagent solution R1in the presence of the resulting hydrogen peroxide, causes oxidation of the leuco dye towards its coloured oxidation form. In many embodiments it may even be explicitly desired for a protease to be used, which does not act specifically in a corresponding fashion.
A markedly greater amount of the protease thermolysin is evidently visible in the bands 4 and 5 in comparison with the other bands of the gel. Preferably the stabiliser is used with a concentration in the range of 0. In certain embodiments the haemolytically acting detergents used are selected for example from the following: In an embodiment the concentration of the stabiliser compound of the general formula IV is in the range of 2.
The man skilled in the art will therefore readily understand that all other embodiments which have the features or combinations of features according to the invention as recited in the claims also fall within the scope of protection of the invention.
In an embodiment the solution contains 0. Actual incubation is then effected, in which the second reagent solution R2 is added to the pre-incubated haemolysate. In an alternative embodiment the SH group-trapping agent, for example NEM, is contained in a reagent solution which is kept separately from the reagent solution and is added, in which there is a leuco dye stabilised with thioalcohols.
Table 2 C shows the AmE loss of the individual calibrators under different storage conditions. The present invention concerns a method of determining the amount of glycated haemoglobin HbA1c in a sample and a reagent kit which can be used in a method of determining the amount of glycated haemoglobin HbA1c in a sample.
The stabiliser used according to the invention can be a single chemical compound of the above-indicated kind a compound which is covered by one of formulae III or III or a mixture of two or more chemical compounds of the above-indicated kind. A method for determining the amount of glycated haemoglobin HbA1cin which—if required—the erythrocytes in a sample are haemolysed, the haemoglobin that is then released—if required—is contacted with a proteolytic agent and the glycated haemoglobin degradation products obtained in this way or otherwise are quantified is disclosed.
Accordingly in certain embodiments of the invention the leuco dye is produced in a solution which for stabilisation of the dye contains at least one compound diasyys the general formula I like for example TCEP and at least one thio compound like for example thiodiglycol. Preferably the aim of the method according to the invention and the reagents according to the invention is to eiasys total haemoglobin determination at the same time as determining the amount of HbA1c.
Accordingly the amount of hydrogen peroxide produced in this step is a measurement in respect of the amount of HbA1c in the sample. In another embodiment the solution contains 0. It is to be deduced from Table 2 A that no HbA1c determination is possible independently of the concentration of calcium ions and EDTA diasyd the absence of zinc ions.
Preferably the zwitterionic detergent has exactly two functional groups of opposite charges so that the molecule overall is electrically neutral. An enzymatic method has also been available for some time, in which a reaction of glycated haemoglobin with a fructosyl amino acid bha1c FAOD is quantified.
Examples of such thio compounds are thiodiglycol, thiomalic acid, thionicotinamide, thio-NAD and mixtures thereof without any limitation of the invention being intended thereby as a result of specifying those examples.
For the purposes of the original disclosure it is dkasys out that diaxys features as can be seen by a man skilled in the art from the present diasus, the drawings and the claims, even if they are described in specific terms only in connection with certain other features, can be combined both individually and also in any combinations with others of the features or hb1ac of features disclosed here insofar as that has not been expressly excluded or technical aspects make such combinations impossible or meaningless.
The above-mentioned reagent kit can be used in a diadys of HbA1c determination in the following manner. Firstly—insofar as is required—sample preparation is effected, in which whole blood is mixed with the haemolysing solution.
The metal ion content of the activation solution can be freely selected in the specified range depending on the respective embodiment involved. In accordance with a first aspect the above-described object of the invention is attained in that there is proposed a method of determining the amount of HbA1c in a sample, in which—insofar as required—method steps a to c are performed.
Haemolysis of the erythrocytes can basically be effected with all mechanical, chemical or osmotic haemolysis means or methods, of which the man skilled in the art knows that they lead dlasys complete haemolysis of the erythrocytes.
In the cases in which the stabilizer includes a zwitterionic detergent which has a haemolytic action or comprises one or more haemolytically acting zwitterionic detergents various variants are possible: In the above-described method of determining the amount of HbA1c in a sample reagents are frequently used, which contain SH ddiasys like for example the above-mentioned thio compounds.
Now a respective different stabilizer in respectively identical concentrations was added to the specified reagent base matrix without stabiliser. The results shown in FIG. A further object that the inventors of the present application set themselves is stabilisation of the leuco dye in the methods of determining the amount of HbA1c in a sample, in which such a leuco dye is used.